Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-26 @ 7:39 PM
Study NCT ID:
NCT01713166
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2012-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Colloid and Crystalloid on the Microcirculatory Alterations During Off-pump Coronary Artery Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2012-10-21', 'studyFirstSubmitQcDate': '2012-10-21', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery slope', 'timeFrame': 'until 2 days after surgery', 'description': 'Recovery slope is a marker of microcirculation. The tissue oxygen saturation (StO2) using InspectraTM StO2 (Hutchinson Technology Inc.,USA) will be recorded continuously. The InspectraTM StO2 probe will be placed on the skin of the thenar eminence and the blood pressure cuff will be wrapped around the arm. After performing vascular occlusion test, the recovery slope will be calculated by the software.'}, {'measure': 'syndecan-1', 'timeFrame': 'until 2 days after surgery', 'description': 'marker of glycocalyx degradation'}], 'secondaryOutcomes': [{'measure': 'lactate', 'timeFrame': 'until 2 days after surgery'}, {'measure': 'StO2 (tissue oxygen saturation)', 'timeFrame': 'until 2 days after surgery'}, {'measure': 'Cytokine', 'timeFrame': 'until 2 days after surgery', 'description': 'Interleukin (IL)-1b, IL-6, IL-8, IL-10, TNF-a'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of crystalloid and colloid, which are used for pump priming solution, on the microcirculatory alterations during cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Off-pump Coronary Artery Bypass Surgery\n\nExclusion Criteria:\n\n* Infection\n* Postoperative use of steroid\n* Liver cirrhosis, Child-Pugh C\n* Renal disease on hemodialysis\n* Patients who cannot receive vascular occlusion test (severe peripheral vascular disease, arteriovenous fistula, burn)\n* EF \\< 40% on the preoperative echocardiography\n* Preoperative use of vasopressors or inotropic agents'}, 'identificationModule': {'nctId': 'NCT01713166', 'briefTitle': 'Effects of Colloid and Crystalloid on the Microcirculatory Alterations During Off-pump Coronary Artery Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'YSJeon_crystalloid vs colloid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plasmalyte solution', 'description': 'Plasmalyte solution infusion to meet the fluid requirements.', 'interventionNames': ['Drug: plasmalyte solution']}, {'type': 'EXPERIMENTAL', 'label': 'Hextend', 'description': '6% Hetastarch administeration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.', 'interventionNames': ['Drug: Hextend']}], 'interventions': [{'name': 'plasmalyte solution', 'type': 'DRUG', 'description': 'plasmalyte solution', 'armGroupLabels': ['Plasmalyte solution']}, {'name': 'Hextend', 'type': 'DRUG', 'description': 'Hetastarch administration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.', 'armGroupLabels': ['Hextend']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yunseok Jeon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}